UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
AMENDMENT NO. 1
TO
FORM 10-K
☒ | Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
for the fiscal year ended December 31, 2017
☐ | Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
for the transition period from to
Commission file number: 001-16133
DELCATH SYSTEMS, INC.
Delaware | 06-1245881 | |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) | |
1633 Broadway, Suite 22C New York, NY | 10019 | |
(Address of principal executive offices) | (Zip Code) |
212-489-2100
(Registrants telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Common Stock, par value $0.01 per share | OTCQB | |
Title of Each Class | Name of Exchange on Which Registered |
Securities registered pursuant to Section 12(g) of the Act: None.
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒ No ☐
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405) is not contained herein, and will not be contained, to the best of the registrants knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company or an emerging growth company. See the definitions of large accelerated filer, accelerated filer, smaller reporting company and emerging growth company in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☒ | |||
Non-accelerated filer | ☐ (Do not check if smaller reporting company) | Smaller reporting company | ☐ | |||
Emerging growth company | ☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
The aggregate market value of the voting common stock held by non-affiliates of the registrant, based on the closing sale price on The NASDAQ Capital Market of $67.87 per share, was $82,287,147 as of June 30, 2017.
At March 16, 2018, the registrant had outstanding 434,997,075 shares of common stock, par value $0.01 per share.
DOCUMENTS INCORPORATED BY REFERENCE
None.
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Item 10. |
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Item 11. |
7 | |||||
Item 12. |
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters |
11 | ||||
Item 13. |
Certain Relationships and Related Transactions, and Director Independence |
12 | ||||
Item 14. |
13 | |||||
Item 15. |
14 | |||||
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EXPLANATORY NOTE
Delcath Systems, Inc., Inc. (the Company, Delcath, we, us, or our) is filing this Amendment No. 1 on Form 10-K/A (Form 10-K/A) to amend our Annual Report on Form 10-K for the year ended December 31, 2017, originally filed with the Securities and Exchange Commission (the SEC) on March 16, 2018 (the Original Form 10-K), to include the information required by Items 10 through 14 of Part III of Form 10-K. This information was previously omitted from the Original Form 10-K in reliance on General Instruction G(3) to Form 10-K, which permits the information in the above referenced items to be incorporated in the Form 10-K by reference from our definitive information statement if such definitive information statement is filed no later than 120 days after our fiscal year-end. We are filing this Form 10-K/A to provide the information required in Part III of Form 10-K because a definitive information statement containing such information will not be filed by the Company within 120 days after the end of the fiscal year covered by the Original Form 10-K. This Form 10-K/A also deletes the incorporation by reference to portions of our definitive information statement from the cover page of the Original Form 10-K.
Pursuant to the rules of the SEC, Part IV, Item 15 has been amended to contain the currently dated certifications from the Companys principal executive officer and principal financial officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. The certifications of the Companys principal executive officer and principal financial officer are attached to this Form 10-K/A as Exhibit 31.3 and Exhibit 31.4, respectively. Because no financial statements have been included in this Form 10-K/A and this Form 10-K/A does not contain or amend any disclosure with respect to Items 307 and 308 of Regulation S-K, paragraphs 3, 4 and 5 of the certifications have been omitted.
Except as described above, this Form 10-K/A does not amend any other information set forth in the Original Form 10-K and we have not updated disclosures included therein to reflect any subsequent events. This Form 10-K/A should be read in conjunction with the Original Form 10-K and with our filings with the SEC subsequent to the Original Form 10-K.
Item 10. | Directors, Executive Officers, and Corporate Governance. |
Information About Directors. The following table sets forth certain information about our director who successfully stood for re-election and aboutour directors whose terms will continue after the Annual Meeting.
Name |
Age | Position with Delcath | Director Since |
|||||||||
Class I DirectorsTerm expiring at the 2019 Annual Meeting |
||||||||||||
William D. Rueckert |
65 | Director | 2014 | |||||||||
Marco Taglietti, M.D. |
58 | Director | 2014 | |||||||||
Class III DirectorsTerms expiring at the 2018 Annual Meeting |
||||||||||||
Simon Pedder, Ph.D. |
57 | Director | 2017 | |||||||||
Roger G. Stoll, Ph.D. |
74 | Chairman | 2008 | |||||||||
Jennifer K. Simpson, Ph.D. |
49 | Director | 2015 |
Simon Pedder, PhD. Dr. Pedder currently serves as Chief Business and Strategy Officer at Athenex, Inc., a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer, a company with which he has been an officer since February 2016. During his long career in drug development, Dr. Pedder has held several leadership positions including President and CEO of Cellectar Biosciences from April 2014 to June 2015, President and CEO of Chelsea Therapeutics from May 2004 to July 2012 and previously, Executive Officer and Vice President of Oncology Pharma Business at Hoffmann-LaRoche, Life Cycle Leader and Global Project Leader of Pegasys/IFN and Head of the Hepatitis Franchise at Hoffmann-LaRoche.
Dr. Pedder led the late stage development and commercial launch of multiple proprietary pharmaceutical products, including Pegasys®, Copegus® and Northera®, which will benefit Delcath as it moves through its phase III clinical trials and NDA submission for the Ocular Melanoma and Intrahepatic Cholangiocarcinoma indications. The Board of Delcath has determined that Dr. Pedder is a key addition due to his expertise in late stage drug development.
Dr. Pedder received his Ph.D. in Pharmacology from the College of Medicine at the University of Saskatchewan in Canada, where he was a faculty member in the Department of Pharmacology at the College of Medicine. Dr. Simon earned a Master of Science in Toxicology from Concordia University in Montreal, Canada, a Bachelor of Science in Environmental Studies from the University of Waterloo in Canada and completed the Roche-sponsored Pharmaceutical Executive Management Program at Columbia Business School in New York City
William D. Rueckert was appointed as a Director in December 2014. Mr. Rueckert has served on many public and private corporate boards in both the life science and banking industries. He is currently President of Oyster Management Group, LLC, an investment partnership specializing in community banking. From 2007 until 2012 he served on the board of Novogen Ltd. (ASX, NASDAQ) a biotechnology company based in Sydney, Australia. He acted as Chairman from 2010 until 2012, and as acting CEO led the restructuring of the company, spinning off its major subsidiary, Marshall Edwards, Inc. (now MEI Pharma, Inc. NASDAQ.) He is currently a director of MEI Pharma, Inc. (NASDAQ), a San Diego based company that is developing novel oncology therapies. Until its sale to H. Lundbeck A/S, he was a director of Chelsea Therapeutics International, Ltd. (NASDAQ) whose drug candidate, Northera, was approved by the FDA in 2014. He has also served on the boards of several banks including Westport Bank and Trust, Lafayette American Bank and Hudson United Bank (all NASDAQ.) He currently serves on the board of Fairfield County Bank, a mutually owned, community bank based in Ridgefield, Connecticut, and Bleachers, Inc., a privately held company that streams live and archived sports and entertainment events from independent schools. Among his civic associations, Mr. Rueckert is a Director and President of the Cleveland H. Dodge Foundation, Co-Chairman of the Board of Trustees of Teachers College, Columbia University, a Director of the Y Retirement Fund, a Trustee of International House, an Emeritus Director of the YMCA of Greater New York, a Trustee of the American University of Beirut and a Director of Wave Hill, Inc. He earned a BA in Spanish
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in 1977 from the University of New Hampshire. The Nominating Committee considered Mr. Rueckerts experience and qualifications, in addition to his relevant executive management and operational pharmaceutical experience, as well as the overall composition of the Board, in making the determination that Mr. Rueckert should serve as director of Delcath.
Roger G. Stoll, Ph.D. was appointed as a Director in December 2008, Executive Chairman in September 2014 and has served as our Chairman since October 1, 2015. From 2002 to 2008, he served as Chairman, Chief Executive Officer and President of Cortex Pharmaceuticals, Inc. (OTCBB: CORX). In August 2008, he was appointed Executive Chairman of its board. He retired from Cortex Pharmaceuticals in August, 2012. From 2001 to 2002, he was a consultant to several east coast venture capital firms and startup ventures. From 1998 to 2001, he was Executive Vice President of Fresenius Medical Care-North America, in charge of the dialysis products division and the diagnostic systems business units, which included hemodialysis machines and dialysis filters equipment. From 1991 to 1998, Dr. Stoll was Chief Executive of Ohmeda, a global leader in anesthetic agents, critical care drugs and related operating room equipment and devices. He also served on the boards of directors of St. Jude Medical and the BOC Group, plc. From 1986 to 1991, Dr. Stoll held several executive management positions at Bayer, AG, including Executive Vice-President and General Manager for its worldwide Diagnostic Business Group. Prior to that, Dr. Stoll worked for American Hospital Supply Corp., where he rose from Director of Clinical Pharmacology to President of its American Critical Care Division. He began his pharmaceutical career at the Upjohn Company in 1972. Dr. Stoll obtained his B.S. in Pharmacy from Ferris State University, obtained a Ph.D. in Biopharmaceutics and Drug Metabolism at the University of Connecticut and was a post-doctoral fellow for two years at the University of Michigan. From 2008 and until its sale to H. Lundbeck A/S, Dr. Stoll served on the board of directors of Chelsea Therapeutics (NASDAQ: CHTP) and was a member of that boards audit and compensation committees. Dr. Stoll in the past also served on the boards of Questcor and Agensys, HIMA and PMA (now PhRMA). Dr. Stoll also serves on the School of Pharmacy Advisory Board of the University of Connecticut. The Nominating Committee considered Dr. Stolls experience and qualifications, in addition to his relevant executive management and operational pharmaceutical and medical device experience, as well as the overall composition of the Board, in making the determination that Dr. Stoll should serve as director of Delcath.
Dr. Marco Taglietti, M.D. was appointed as a Director in December 2014. Dr. Taglietti serves as CEO and on the Board of Directors of NASDAQ-listed SCYNEXIS, Inc., a pharmaceutical company committed to the discovery, development and commercialization of novel anti-infectives. Prior to its acquisition in February 2014, Dr. Taglietti served as Executive Vice President, Research and Development, and Chief Medical Officer of Forest Laboratories. He also served as President of the Forest Research Institute. Prior to joining Forest Labs in 2007, Dr. Taglietti held the position of Senior Vice President, Head of Global Research and Development, at Stiefel Laboratories, Inc. for three years. He joined Stiefel after 12 years at Schering-Plough Corporation where he last held the position of Vice President, Worldwide Clinical Research for Anti-Infectives, Oncology, CNS, Endocrinology and Dermatology. Dr. Taglietti began his career at Marion Merrell Dow Research Institute. He received his medical degree and board certifications from the University of Pavia in Italy. The Nominating Committee considered Dr. Tagliettis experience and qualifications, in addition to his relevant executive management and operational pharmaceutical experience, as well as the overall composition of the Board, in making the determination that Dr. Taglietti should serve as director of Delcath.
In addition, information concerning Jennifer K. Simpson, one of our Directors and our President and Chief Executive Officer, is provided under Information About Executive Officers
Information About our Executive Officers
The following table provides information concerning the current executive officers of Delcath.
Name |
Age | Office Currently Held | ||
Jennifer K. Simpson, Ph.D. |
48 | President and Chief Executive Officer | ||
Barbra C. Keck, M.B.A. |
39 | Chief Financial Officer and Secretary | ||
John Purpura |
55 | Executive Vice President, Global Head of Operations |
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The following is a brief description of the business experience of the following officers:
Jennifer K. Simpson was appointed as a Director in October 2015. Dr. Simpson joined Delcath as Executive Vice President, Global Marketing in March 2012 and was promoted to Executive Vice President, Global Head of Business Operations in April 2013 and Interim Co-President and Co-ChiefExecutive Officer, Executive Vice President, Global Head of Business Operations in September 2013. In September 2014, Dr. Simpson was named Interim President and Chief Executive Officer and named President and Chief Executive Officer in October 2015. From May 2011 to March 2012, Dr. Simpson served as the Vice President, Global Marketing, Oncology Brand Lead at ImClone Systems, Inc. (a wholly owned subsidiary of Eli Lilly and Company), where she was responsible for all product commercialization activities and launch preparation for one of the late-stage assets. From June 2009 to May 2011, Dr. Simpson served as the Vice President, Product Champion and from 2008 to 2009 as the Associate Vice President, Product Champion for ImClones product Ramucirumab. From 2006 to 2008, Dr. Simpson served as Product Director, Oncology Therapeutics Marketing at Ortho Biotech (now Janssen Biotech), a Pennsylvania-based biotech company that focuses on innovative solutions in immunology, oncology and nephrology. Earlier in her career, Dr. Simpson spent over a decade as a hematology/oncology nurse practitioner and educator. Dr. Simpson earned a Ph.D. in Epidemiology from the University of Pittsburgh, an M.S. in Nursing from the University of Rochester, and a B.S. in Nursing from the State University of New York at Buffalo.
Barbra C. Keck joined Delcath as Controller in January 2009, was promoted to Vice President in October 2009, to Senior Vice President in March 2015 and to Chief Financial Officer in February 2017. Prior to joining Delcath, she was an audit assistant with Deloitte & Touche, LLP from August 2008 to December 2008. From June 2006 to August 2008, Ms. Keck was the Assistant to the Vice President and Dean of Baruch College, Zicklin School of Business, and from September 2005 to May 2006 she was the Donor Relations and Communications Manager for Young Audiences New York. From 2002 to 2005, Ms. Keck was the Manager, UD Arts Series at the University of Dayton, where she also served as the Manager, Arts and Cultural Events from 1999 to 2002. Between those positions, from 2002 to 2003, she was the Director of Teacher Programs at the Muse Machine. Ms. Keck served as the General Manager of Dayton Bach Society and the Manager of UD Arts Series from 1999 to 2002. She earned her M.B.A. in Accountancy from Baruch College and Bachelor of Music in Music Education from the University of Dayton.
John Purpura joined Delcath as Executive Vice President, Regulatory Affairs and Quality Assurance in November 2009 and was promoted to Executive Vice President, Global Head of Operations on July 19, 2016. Prior to joining Delcath, he was with Bracco Diagnostics (formerly E-Z-EM,Inc.) as Vice President and then Executive Director of International Regulatory Affairs from 2007 to 2008 and Head of Regulatory Affairs for North America and Latin America from 2008 to 2009. Prior to E-Z-EM, Inc., Mr. Purpura had an 11-year career with Sanofi-Aventis, ultimately serving as Associate Vice President for Regulatory CMC from 2005 to 2007. From 1985 to 1995, he had various quality and regulatory management roles with Bolar Pharmaceuticals, Luitpold Pharmaceuticals and Eon Labs Manufacturing. He earned his M.S. in Management & Policy and B.S. degrees in Chemistry and Biology at the State University of New York at Stony Brook.
Board of Directors. We have currently have five directors serving on the Board of Directors. The Board of Directors oversees the business affairs of the Company and monitors the performance of management. In accordance with our corporate governance principles, our Board does not involve itself in day-to-day operations. The directors keep themselves informed through discussions with the Chairman of the Board, Roger G. Stoll, Jennifer K. Simpson, in her capacity as Director and Chief Executive Officer, or CEO, and other key executives, and by reading the reports and other materials that management sends them and by participating in Board and committee meetings. Our directors hold office until their successors have been elected and qualified unless the director resigns or is removed or by reason of death or other cause is unable to serve in the capacity of director.
Board Independence. The Board has determined that four of our five directors (each of Simon Pedder, Roger Stoll, William D. Rueckert and Marco Taglietti) are independent directors within the meaning of the NASDAQ listing rules.
Attendance. The Board of Directors met 12 times in 2017 (including regularly scheduled and annual meetings). During 2017, each director attended at least 75% of the aggregate of: (i) the total number of meetings of the Board (held during the period for which he or she served as a director) and (ii) the total number of meetings held by all committees of the Board of Directors on which he or she served (held during the period that he or she served). It is Delcaths policy that, absent unusual or unforeseen circumstances, all directors are expected to attend annual meetings of stockholders, and all attended our 2016 Annual Meeting.
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Board Leadership Structure. Roger G. Stoll, Ph.D. was appointed Executive Chairman effective September 2014 and designated Chairman in connection with the appointment of Dr. Simpson as director effective October 2015. Dr. Stoll has been a member of the Board of Directors since 2008.
It is our policy to separate the Chairman and Chief Executive Officer roles. We believe this structure is appropriate for Delcath because it allows our President and CEO to concentrate on Delcaths day-to-day operations, while providing for effective oversight by the Chairman, who is involved in strategic and key matters, such as business strategy, major transactions and the broader business of Delcath. For a company like Delcath that is focused on the development, approval and commercialization of a specialized product in an extremely technical, highly regulated and intensely competitive industry, we believe our President and CEO is in the best position to lead our management team, in part because of the depth of her experience in conducting clinical trials in oncology, and to respond to the current pressures and needs of a company the stage of growth and development of Delcath, with assistance from our Chairman who also focuses the Boards attention on the broader issues of corporate business strategy and corporate governance. We believe that splitting the roles between Chairman, on the one hand, and President and CEO, on the other hand, minimizes any potential conflicts that may result from combining the roles of CEO, President and Chairman, and maximizes the effectiveness of our management and governance processes to the benefit of our stockholders. Our President and CEO and Chairman regularly consult with each other as part of this structure.
Boards Role in Risk Oversight. The Board as a whole is responsible for risk oversight, with reviews in certain areas being conducted by the relevant Board committees. Each of the Boards committees oversees the management of risks associated with their respective areas of responsibility. In performing this oversight function, the committees are assisted by management which provides visibility about the identification, assessment and monitoring of potential risks and managements strategy to mitigate such risks. Key members of management responsible for a particular area report directly to the Board committee charged with oversight of the associated function and, if the circumstances require, the whole Board. The Board committees review various risk exposures with the full Board and otherwise keep the full Board abreast of the committees risk oversight activities throughout the year, as necessary or appropriate.
Risk Assessment of Compensation Programs. Our Compensation and Stock Option Committee annually evaluates whether our compensation programs encourage excessive risk-taking by employees at the expense of long-term Company value. Based upon its assessment, including a review of the overall annual award limitations and individual annual limitations in the Delcath 2009 Stock Incentive Plan and the Compensation Committees role in the consideration and approval of certain awards, the Compensation and Stock Option Committee does not believe that our compensation programs encourage excessive or inappropriate risk-taking, motivate imprudent risk-taking or create risks that are reasonably likely to have a material adverse effect on the Company.
Director Continuing Education. We require our directors to attend, at least annually, educational programs provided by various universities, stock exchanges and other regulatory agencies to assist our directors in maintaining or enhancing their skills and abilities as directors and to update their knowledge and understanding of the pharmaceutical, medical device and biopharma industries and the regulatory environment in which Delcath operates and to which it is subject.
Board Committees. Our Board has three standing committees: an Audit Committee, a Compensation and Stock Option Committee and a Nominating and Corporate Governance Committee. No individual director is the chairman of more than one committee.
Audit Committee. The Audit Committee provides assistance to the Board in fulfilling its oversight responsibilities with respect to the Companys financial statements, the Companys system of internal accounting and financial controls and the independent audit of the Companys financial statements. Functions of the Audit Committee include:
| the selection, evaluation and, where appropriate, replacement of our outside auditors; |
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| an annual review and evaluation of the qualifications, performance and independence of our outside auditors; |
| the approval of all auditing services and permitted non-audit services provided by our outside auditors; |
| the review of the adequacy and effectiveness of our accounting and internal controls over financial reporting; and |
| the review and discussion with management and with our outside auditors of the Companys financial statements to be filed with the Securities and Exchange Commission (the SEC). |
The Board has determined that each member of the Audit Committee, William D. Rueckert (Chair), and Simon Pedder and Roger Stoll qualifies as an audit committee financial expert as defined by SEC rules. During 2017, the Audit Committee met four times. Each member of the Audit Committee is independent within the meaning of the NASDAQ listing rules and otherwise meets the financial statement proficiency requirements of the NASDAQ listing rules. The Audit Committee has a written charter, which is available on our website; go to www.delcath.com, click on Investors, then Corporate Governance.
Compensation and Stock Option Committee. The Compensation and Stock Option Committee (the Compensation Committee) assists the Board of Directors in the discharge of the Boards responsibilities with respect to the compensation of Delcaths directors, executive officers, and other key employees and consultants. The Compensation Committee establishes our overall compensation philosophy and is authorized to approve the compensation payable to our executive officers, including our named executive officers, and other key employees, including all perquisites, equity incentive awards, cash bonuses, and severance packages. The Compensation Committee also administers certain of our employee benefit plans, including its equity incentive plans, and is responsible for assessing the independence of compensation consultants and legal advisors. The Compensation Committee has concluded that each of Wexler, Burkhart, Hirschberg & Unger, LLP, outside legal counsel to the Compensation Committee and the Company, as well as Pearl Meyer & Partners, compensation consultant to the Compensation Committee, qualified as independent. The Compensation Committee exercises sole power to retain compensation consultants and advisors and to determine the scope of the associated engagements. The current members of the Compensation and Stock Option Committee are Marco Taglietti (Chair) and William D. Rueckert, Simon Pedder and Roger Stoll, each of whom is independent within the meaning of the NASDAQ listing rules. During 2017, the Compensation and Stock Option Committee met nine times. The Compensation and Stock Option Committee has a written charter, which is available on our website; go to www.delcath.com, click on Investors, then Corporate Governance.
Nominating and Corporate Governance Committee. The Nominating and Corporate Governance Committee (the Nominating Committee) is responsible for identifying individuals qualified to become Board members, and recommends to the Board the director nominees to be proposed by the Board for election by the stockholders (as well as any director nominees to be appointed by the Board to fill interim vacancies). The Nominating Committee also recommends the directors to be selected for membership on each Board committee.
The Nominating Committee is also responsible for developing and recommending to the Board appropriate corporate governance guidelines and policies, and for leading the Board in its annual review of the Boards performance.
The current members of the Nominating Committee are Roger Stoll (Chairman), William D. Rueckert and Marco Taglietti, each of whom is independent, within the meaning of the NASDAQ listing rules. During 2017, the Nominating Committee met one time. The Nominating Committee has a written charter, which is available on our website; go to www.delcath.com, click on Investors, then Corporate Governance.
The Nominating Committee, with, when it deems it necessary, the assistance of a third-party search firm, identifies candidates for director nominees. In considering candidates for the Board, the Nominating Committee considers each candidates credentials as a whole, including, but not necessarily limited to, outstanding achievement in a candidates personal career, broad and relevant experience, integrity, sound and independent judgment, experience and knowledge of the business environment and markets in which the Company operates, business acumen, and willingness and ability to devote adequate time to Board duties. The Nominating Committee considers the diversity of its members in the context of the Board as a whole, including the personal characteristics, experience and background of directors and nominees to facilitate Board deliberations that reflect a broad range of perspectives.
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Recommendations by Stockholders of Director Nominees. The Nominating Committee will consider any recommendation by a stockholder of a candidate for nomination as a director. If a stockholder wants to recommend a director candidate for consideration by the Nominating Committee, the stockholder should submit the name of the proposed nominee, together with the reasons why the stockholder believes the election of the candidate would be beneficial to the Company and its stockholders and the information about the nominee that would be required in a proxy statement requesting proxies to vote in favor of the candidate. The stockholders submission must be accompanied by the written consent of the proposed nominee to being nominated by the Board and the candidates agreement to serve if nominated and elected. Any such submission should be directed to the Nominating Committee at Delcaths principal office, 1633 Broadway, Suite 22C, New York, New York 10019. If a stockholder intends to nominate a person for election to the Board of Directors at an annual meeting, the stockholder must provide Delcath with written notice of his or her intention no later than the deadline for receiving a stockholder proposal for inclusion in Delcaths proxy statement for such meeting (as described below under the heading Stockholder Proposals For the 2018 Annual Meeting) and must otherwise comply with our amended and restated certificate of incorporation. Copies of any recommendation received in accordance with these procedures will be distributed to each member of the Nominating Committee. One or more members of the Nominating Committee may contact the proposed candidate to request additional information.
Stockholder Communications with the Board of Directors. Any stockholder wishing to communicate with the Board or with any specified director should address his or her communication to the Board of Directors or to the particular director(s) in care of the Corporate Secretary, Delcath Systems, Inc., 1633 Broadway, Suite 22C, New York, New York 10019. All such written communication, other than items determined by our legal counsel to be inappropriate for submission to the intended recipient(s), will be submitted to the Board or to the particular director(s). Any stockholder communication not so delivered, will be made available upon request to any director. Examples of stockholder communications that would be considered inappropriate for submission include, without limitation, customer complaints, business solicitations, product promotions, job inquiries, junk mail and mass mailings, as well as material that is unduly hostile, threatening, illegal or similarly unsuitable.
Code of Ethics. We maintain a Code of Business Conduct and Ethics (Code) that applies to all employees, including our principal executive officer, principal financial officer, principal accounting officer, controller and persons performing similar functions, and including our independent directors, who are not employees of the Company, with regard to their Delcath-related activities. The Code incorporates guidelines designed to deter wrongdoing and to promote honest and ethical conduct and compliance with applicable laws, rules and regulations. The Code also incorporates our expectations of our employees that enable us to provide accurate and timely disclosure in our filings with the SEC and other public communications. In addition, the Code incorporates guidelines pertaining to topics such as complying with applicable laws, rules, and regulations; insider trading; reporting Code violations; and maintaining accountability for adherence to the Code. The full text of our Code is published on our web site at http://delcath.com/investors/governance. We intend to disclose future amendments to certain provisions of our Code, or waivers of such provisions granted to our principal executive officer, principal financial officer or principal accounting officer and persons performing similar functions on our web site.
REPORT OF THE AUDIT COMMITTEE
The Audit Committee reviewed and discussed the Companys audited financial statements for the fiscal year ended December 31, 2017, with management and Grant Thornton, the Companys independent registered public accounting firm for the fiscal year ended December 31, 2017. The Audit Committee also discussed with Grant Thornton the matters required to be discussed by the Statement on Auditing Standards No. 16, as amended, as adopted by the Public Company Accounting Oversight Board in Rule 3200T regarding Communication with Audit Committees. The Audit Committee has received and reviewed the written disclosures and the letter from Grant Thornton required by applicable requirements of the Public Company Accounting Oversight Board regarding Grant Thorntons communications with the Audit Committee concerning independence, and has discussed with Grant Thornton its independence from the Company.
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Based on the review and discussions referred to above, the Audit Committee recommended to the Board of Directors that the Companys audited financial statements be included in the Companys Annual Report on Form 10-K for the fiscal year ended December 31, 2017, for filing with the Securities and Exchange Commission.
Submitted by the Audit Committee of the Board of Directors,
William Rueckert (Chair)
March 16, 2018
SECTION 16(A) BENEFICIAL OWNERSHIP REPORTING COMPLIANCE
Section 16(a) of the Securities Exchange Act of 1934, as amended, requires our directors and officers, and persons who are beneficial owners of more than 10% of our common stock to file with the Securities and Exchange Commission reports of holdings and changes in beneficial ownership of Delcaths equity securities. Based on a review of copies of reports furnished to Delcath or written representations that no reports were required, we believe that all reports were timely filed in 2017.
Delcath maintains a Code of Business Conduct and Ethics (Code) that applies to all employees, including its principal executive officer, principal financial officer, principal accounting officer, controller and persons performing similar functions, and including its independent directors, who are not employees of the Company, with regard to their Delcath-related activities. The Code incorporates guidelines designed to deter wrongdoing and to promote honest and ethical conduct and compliance with applicable laws, rules and regulations. The Code also incorporates Delcaths expectations of its employees that enable the Company to provide accurate and timely disclosure in its filings with the SEC and other public communications. In addition, the Code incorporates guidelines pertaining to topics such as complying with applicable laws, rules, and regulations; insider trading; reporting Code violations; and maintaining accountability for adherence to the Code. The full text of the Companys Code is published on its web site at http://delcath.com/investors/governance and is incorporated by reference herein. The Company intends to disclose future amendments to certain provisions of its Code, or waivers of such provisions granted to its principal executive officer, principal financial officer, principal accounting officer or controller and persons performing similar functions on its web site. Except as expressly stated herein, the information contained on Delcaths website does not constitute a part of this Annual Report on Form 10-K and is not incorporated by reference herein.
Item 11. | Executive Compensation. |
Our Compensation and Stock Option Committee is responsible for formulating and establishing our overall compensation philosophy with respect to our executive officers. The Company believes that a strong executive management team comprised of talented individuals in key positions at the Company is critical to the development and growth of our business and to increasing stockholder value. Accordingly, a key objective of executive compensation is to attract and retain talented and experienced individuals, while motivating them to perform and make decisions consistent with the Companys business objectives, goals and culture. We emphasize pay-for-performance by linking executive compensation to Company performance. For each executive, the amount of pay that is actually realized is primarily driven by the Companys performance and each executives contribution to that performance.
Our Compensation Committee engaged an independent compensation consulting firm, Pearl Meyer, to assist with the formulation of our executive compensation programs for 2017.
Our Compensation Committee considers the input it receives from our stockholders when designing and evaluating our executive compensation practices. Compensation Components. The three primary components of executive compensation are base salary, annual incentive cash awards and long-term equity incentive awards:
| Base Salary. We pay our executive officers a base salary, which our Compensation Committee reviews and determines annually. Base salaries are used to compensate our executive officers for performing the core responsibilities of their positions and to provide them with a level of security with respect to a portion of |
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their total compensation. Base salaries are set in part based on the executives unique skills, experience and expected contribution to the Company, as well as individual performance, including the impact of such performance on our business results, and the period of the executives performance. Decisions regarding base salary increases take into account the executives current base salary, third-party benchmark and survey data, and the salary compensation paid to executive officers within and outside the Company, as well as the Companys overall performance, its ability to afford such increases, its success in achieving its operational and strategic goals and objectives, and the executive officers contribution to Company performance. |
| Annual Incentive Cash Awards. Annual incentive compensation is intended to establish a direct correlation between annual cash awards and the performance of the Company. The Companys Annual Incentive Plan (AIP) is an annual incentive cash bonus plan designed to align the interests of participants with the interests of the Company and its stockholders. The AIP is designed to strengthen the link between a participants pay and his or her overall performance and the Companys performance, focus participants on critical individual and corporate objectives, offer a competitive cash incentive, and encourage and reward performance and competencies critical to the Companys success. |
| Long-Term Incentive Compensation. In addition to using base salaries and annual incentive cash bonuses, which our Compensation and Stock Option Committee views as short-term compensation, a portion of our executive compensation is in the form of long-term equity compensation. Our Long-Term Incentive Plan (LTIP) is an annual equity-based incentive plan designed to align participants interests with those of the Company and its stockholders by rewarding participants for their contributions to the long-term success of the Company. The LTIP is designed to incentivize Company leaders to focus on the long-term performance of the Company, offer participants competitive, market-based long-term incentive award opportunities, and strengthen the link between a participants compensation and his or her overall performance and the Companys overall long-term performance. We believe the LTIP assists us in achieving an appropriate balance between our short- and long-term. |
Interface of Executive Officers with Compensation Committee in Determining Compensation. The Compensation Committee, based on input from the Companys Chief Executive Officer and Chairman, determines the compensation of our executive officers. The CEO and Chairman assist the Compensation Committee by providing performance assessments and compensation recommendations for each of the Companys executive officers, including the named executive officers (other than the CEO). The final decisions regarding the compensation for the named executive officers is then independently assessed and approved by the Compensation Committee. Other than completing a self-evaluation performance review, and submitting it to the Compensation Committee, the CEO does not participate in the formulation or discussion of her compensation. The Chairman provides the performance review for the CEO and submits that review to the Compensation Committee for its consideration. The Chairman also has discussions with the full committee related to all the performance items submitted for the named executive officers. Upon completion of these reviews, final decisions related to the compensation of the CEO require approval of the full Board of Directors after recommendations are made by the Compensation Committee.
Role of Compensation Consultants. The Compensation Committee retained PM&P as its independent compensation consultant to assist the Compensation Committee in evaluating executive compensation programs. PM&P reports directly to the Compensation Committee, and is not permitted to perform services for management unless approved by the Compensation Committee.
Inputs to Committee Decision Making.
Performance Evaluation Process. The Company utilizes a formal annual performance review program to evaluate our executives competencies, as well as individual performance objectives. The competencies in the program include: commitment to quality, integrity and ethics, as well as results oriented, teamwork, dependability, job knowledge and productivity. Each executive performs a self-evaluation and also is rated by the CEO on his or her competencies at year end and a final average total rating is calculated. Corporate performance objectives, which are set at the beginning of the year, are linked to the Companys overall performance and attainment of these objectives. Following completion of the performance year, the CEO submits performance evaluations and recommendations for each executive to the Executive Chairman who after review with the CEO then submits information to the Compensation Committee. The Committee reviews the completed individual performance evaluation forms for our executive officers including the CEO and assesses the Companys overall performance relative to the achievement of corporate objectives. The information gathered as part of this evaluation process was used by our Compensation Committee to assist it in making compensation decisions. While the Company conducts its performance evaluations annually, the 2017 AIP was based solely on the achievement of corporate performance goals.
Peer Group Review. The Compensation Committee, with the assistance of PM&P, generally reviews the peer group on a regular basis. Due to the unique nature of the Companys business, we continually face challenges as we strive to develop the most appropriate mix of companies to comprise our peer group. The challenges we face include:
| We are an early commercial stage company with limited product revenues ($1.1M in 2014). As a result, a typical revenue range for peer selection purposes is more challenging due to our relatively small size. |
| We are a medical device company and specialty pharmaceutical company. Our proprietary technology is designed to administer high-dose chemotherapy and other therapeutic agents to diseased organs or regions of the body, while controlling the systemic exposure of those agents. Our CHEMOSAT System for Melphalan is classified as a class IIb medical device and has been approved in Europe. In the United States, we are considered a drug device combination product regulated under a 505(b)(2) new drug application which is not currently approved yet. (As previously discussed, we received a complete response letter from the U.S. FDA to our NDA.) Because our product is regulated as both a device and a drug in the U.S. only, we have to recruit executive talent who have background and skill sets from both industries and who have experience in both device and drug development from larger, more established companies. |
| There are very few peers across the medical device and pharmaceutical industries with a similar combination product which is considered a drug in certain regions and classified as a device in other regions, and so exact peers for us are difficult to identify. |
Generally, the Compensation Committee considers each of the above challenges as well as the following selection criteria to select its peer group:
| We focused on companies with industry/product similarityDrug Delivery Systems/Medical Device companies with a focus on cancer/oncology and Pharmaceuticals/Biopharmaceuticals/Biotherapeutics companies with a cancer focused drug. As a result, multiple GICS sub-industries were reviewed and considered. |
| We used a range of revenue from $0 $100M to develop a pool of potential firms to consider. |
| We then narrowed the pool of potential companies based on market capitalization and other secondary factors (R&D expenses, number of employees, further test of business model and product similarity, etc.). |
Due to the changes in the Companys size and market capitalization, the Compensation Committee believed that a re-assessment of the peer group was warranted in 2014. The Compensation Committee, the Chairman, and management worked with PM&P to revise the peer group to reflect the smaller size of Delcath and the increased intensity in the clinical development activities. The following table reflects the new peer group which was reviewed and approved by the Compensation Committee and the full board of Delcath before being implemented:
Company |
Industry(1) |
Revenue(2) | Market Capitalization(3) |
|||||||
Accurexa Inc. | Healthcare Equipment | $ | 0 | $ | 17 | |||||
Adamis Pharmaceuticals Corporation | Pharmaceuticals | $ | 0 | $ | 49 | |||||
Aethlon Medical, Inc. | Healthcare Equipment | $ | 1 | $ | 33 | |||||
Arno Therapeutics, Inc. | Biotechnology | $ | 0 | $ | 27 | |||||
ArQule Inc. | Biotechnology | $ | 11 | $ | 71 | |||||
BSD Medical Corp. | Healthcare Equipment | $ | 5 | $ | 23 | |||||
Celator Pharmaceuticals, Inc. | Biotechnology | $ | 0 | $ | 65 | |||||
Cellectar Biosciences, Inc. | Biotechnology | $ | 0 | $ | 16 | |||||
Celsion Corp. | Biotechnology | $ | 1 | $ | 59 | |||||
Champions Oncology, Inc. | Life Sciences Tools and Services | $ | 10 | $ | 46 | |||||
Cytosorbents Corporation | Healthcare Equipment | $ | 4 | $ | 70 | |||||
Emisphere Technologies, Inc. | Pharmaceuticals | $ | 0 | $ | 23 | |||||
MetaStat, Inc. | Life Sciences Tools and Services | $ | 0 | $ | 20 | |||||
Nephros, Inc. | Healthcare Equipment | $ | 2 | $ | 19 | |||||
OncoGenex Pharmaceuticals, Inc. | Biotechnology | $ | 35 | $ | 59 | |||||
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Median | | $ | 1 | $ | 33 | |||||
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Delcath Systems Inc. | Health Care Equipment | $ | 1 | $ | 19 | |||||
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(1) | Reflects the sub-industry as defined under Global Industry Classification Standard. |
(2) | Data from S&P Capital IQ database, as of most recent quarter end at the time the analysis was completed (October 2014). |
(3) | Data from S&P Capital IQ database, as of most recent month end at the time the analysis was completed (October 2014). |
The Committee believes this peer group continues to represent a reasonable mix of companies to appropriately address the concerns presented above and currently reflects the size and business model of our Company.
Benchmark Analyses. The Compensation Committee reviews our executive officers overall compensation packages in 2017. The analysis includes a review of total target compensation for each executive officer as well as for each component of compensation, relative to executives in comparable positions or with comparable roles.
The Compensation Committee generally targets around the median percentile range of the competitive market for the various elements of compensation, yet individual executives may be paid above or below this point depending upon, among other factors, the skills and experience, tenure in the position, overall individual performance and additional responsibilities of the executive. In addition to evaluating the peer group data, the Compensation Committee also uses survey data for a broader pharmaceutical, medical device and biopharma industry perspective. Overall, the Compensation Committee attempts to maintain individual compensation within competitive ranges, with some exceptions based on prior experience and compensation history for each individual.
Pay Mix. The Compensation Committee seeks to achieve executive compensation objectives through the use of a mix of compensation elements for each executive officer. While the Compensation Committee generally strives to award a significant amount of each NEOs target total direct pay opportunity in the form of variable, rather than fixed compensation, it does not have rigid guidelines or formulas in determining the amount and mix of compensation elements for each executive officer.
Base Salary. Effective February 2017, Barbra Keck, previously the Senior Vice President of Finance, Principal Accounting Officer and Principal Financial Officer of the Company, became the Chief Financial Officer of the Company. In connection with her promotion to Chief Financial Officer, Ms. Kecks annual base salary was increased from $247,200 in 2016 to $300,000 in 2017.
The following table summarizes the amount of base salary and year-over-year increase for each of our named executive officers for 2016 and 2017.
Executive |
Hire Date | 2015 Base Salary |
Percent Increase in 2016 |
2016 Base Salary |
Percent Increase in 2017 |
2017 Base Salary |
||||||||||||||||
Jennifer K. Simpson, Ph.D. |
3/23/2012 | $ | 427,000 | 3.0 | % | $ | 439,810 | 3.0 | % | $ | 453,004 | |||||||||||
Barbra C. Keck, M.B.A. |
1/5/2009 | $ | 240,000 | 3.0 | % | $ | 247,200 | 21.4 | % | $ | 300,000 | |||||||||||
John Purpura, M.S. |
11/16/2009 | $ | 270,569 | 13.5 | % | $ | 307,000 | 3.0 | % | $ | 316,210 |
Annual Incentive Plan. Under the AIP, annual incentive target award opportunities are expressed as a percentage of a participants actual base salary for the performance year, beginning January 1. The following table sets forth, for each executive, the applicable target bonus percentage of base salary to which each executive could have been entitled, as well as the actual bonus earned based on company performance in 2017:
Target Incentive Bonus Opportunity |
2017 Incentive Award Earned |
|||||||||||||||
Executive |
Target Bonus Expressed as % of Base Salary |
Dollars ($) |
Actual Payout as a % of Target Bonus |
Dollars ($) |
||||||||||||
Jennifer K. Simpson, Ph.D. |
50.0 | % | $ | 226,502 | 65.0 | %(1) | $ | 147,226 | (1) | |||||||
Barbra C. Keck, M.B.A. |
35.0 | % | $ | 105,000 | 65.0 | %(1) | $ | 68,250 | (1) | |||||||
John Purpura, M.S. |
45.0 | % | $ | 142,295 | 65.0 | %(1) | $ | 92,491 | (1) |
(1) | Amounts determined as of the date of filing this Amendment No. 1 but have not yet been paid. |
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For 2017, AIP goals were based entirely on Company performance to focus all the executives on the same critical challenges facing the Company.
Company performance in 2017 has been measured based upon achievement of objectives in the following areas: (1) Clinical Trials; (2) Capital; and (3) Sales.
Actual 2017 corporate performance, including assigned weighting and actual achievement in each area is still undergoing assessment by our Compensation Committee.
Long Term Incentive Plan. Grants under the LTIP are typically comprised of a mix of restricted stock and stock option awards granted in the first quarter of each year with the number of shares subject to the awards designed to deliver a competitive value targeted at the mid-market of the executive compensation comparison group. These guidelines are reviewed periodically based on prevailing compensation comparison group levels, however, and the Compensation and Stock Option Committee then uses these guidelines to determine long-term equity incentive awards for our named executive officers based upon a holistic assessment of Company and individual performance for the prior year and its view of the appropriate incentives to best help achieve the Companys business objectives. Our ability to provide awards at the mid-market level has been difficult to do in the past few years due to share availability. Such awards in the past few years have typically been at or below the market 25th percentile.
There were no long-term equity awards to our named executive officers in 2017. Due to the lack of available shares for issuance under the Companys Delcath 2009 Stock Incentive Plan, the Board of Directors did not grant any long-term equity awards to our named executive officers in 2017 which in no way should create any negative inference concerning the Compensation and Stock Option Committees evaluation of their performance.
Employment Agreements, Executive Security Agreements and Confidentiality and Restrictive Covenant Agreements.
Executive Security Agreements. In early 2017, Dr. Simpson, Ms. Keck and Mr. Purpura (the Executives) each executed an Executive Security Agreement (Executive Agreements) with the Company. Each executive is employed at will. The Executive Agreements provide for the payment of severance to each of the Executives upon a qualifying termination (a termination which is involuntary but not for cause or a termination for good reason as defined in their employment agreements with the Company) to be paid within 10 days of such event as follows: (i) all base salary owed to the date of the qualifying event, (ii) a one-time lump sum fee equal to the Executives monthly base salary for a term of two years for Jennifer Simpson and 18 months for Barbra Keck and John Purpura, and (iii) COBRA payments should the Executive remain on the Companys health benefit plans. The Executive would also be entitled to any annual incentive payments due by March 15th of the following year. The term of the Executive Agreements continues until terminated by mutual agreement of each Executive and the Company.
Additional Benefits; 401(k) Plan. All salaried employees participate in a variety of retirement, health and welfare, and paid time-off benefits designed to enable the Company to attract and retain a talented workforce in a competitive marketplace. These benefits and related plans help ensure that the Company has a productive and focused workforce. The Company utilizes a 401(k) savings plan to enable employees to plan and save for retirement. The Company does not provide matching contributions.
Other Compensation. As an early commercial stage company, the Company does not have pension or deferred compensation plans or arrangements.
Prohibition on Hedging and Pledging. Pursuant to the Companys insider trading policy, the Company prohibits any director, officer or other employee from hedging or pledging Company securities.
Clawback Policy. We have not yet adopted a formal clawback policy because we await the issuance of clarifying regulations by the SEC regarding required elements of any such clawback policy. As required by Section 954 of the Dodd-Frank Wall Street Reform and Consumer Protection Act, we intend to adopt a clawback policy upon issuance by the SEC of final rules regarding clawbacks.
Internal Revenue Code Section 162(m) Considerations. Section 162(m) of the Internal Revenue Code generally denies publicly-held corporations a federal income tax deduction for compensation exceeding $1,000,000 paid to the Chief Executive Officer and each of the three next most highly paid executive officers serving as such at year end, excluding the Chief Financial Officer. While the Compensation Committee takes Section 162(m) into account when determining the type and amount of compensation to provide to the named executive officers, the Compensation Committee may award compensation that is not deductible if it believes it is reasonable and appropriate to do so.
Summary Compensation Table.
The following table sets forth the total compensation awarded to, earned by or paid to: (i) each person who served as a principal executive officer during 2017, and (ii) our two other most highly-compensated executive officers who were serving as executive officers on December 31, 2017. We refer to these individuals as our named executive officers.
Name & Position |
Year | Salary ($) |
Bonus ($) |
Stock Awards ($)(2) |
Option Awards ($) |
Non-Equity Incentive Plan Compensation ($) |
All Other Compensation ($) |
Total ($) |
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Jennifer K. Simpson, Ph.D. |
2017 | 453,004 | 147,226 | (3) | 7,476 | | | | 607,706 | (3) | ||||||||||||||||||||||
President and Chief Executive Officer |
2016 | 439,810 | 149,535 | | | | | 589,345 | ||||||||||||||||||||||||
Barbra C. Keck, M.B.A. |
2017 | 293,400 | 68,250 | (3) | 4,788 | | | | 366,438 | (3) | ||||||||||||||||||||||
Chief Financial Officer and Secretary(1) |
2016 | 247,200 | 58,834 | | | | | 306,034 | ||||||||||||||||||||||||
John Purpura, M.S. |
2017 | 316,210 | 92,491 | (3) | 7,140 | | | | 415,841 | (3) | ||||||||||||||||||||||
Executive Vice President Global Head of Operations |
2016 | 291,442 | 93,942 | | | | | 385,384 |
(1) | Effective February 2017, Ms. Barbra C. Keck, previously the Senior Vice President of Finance, Principal Accounting Officer and Principal Financial Officer of the Company, became the Chief Financial Officer of the Company. |
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(2) | Due to the lack of available shares for issuance under the Companys Delcath 2009 Stock Incentive Plan, the Board of Directors did not grant any long-term equity awards to our named executive officers in 2016 which in no way should create any negative inference concerning the Compensation and Stock Option Committees evaluation of their performance. |
(3) | Amounts determined as of date of filing this Amendment No. 1 but have not yet been paid. |
Grants of Plan-Based Awards Table2017. The following table sets forth grants of plan-based awards made during the fiscal year ended December 31, 2017 to the named executive officers. All equity grants were made pursuant to the 2009 Plan.
Name |
Grant Date (equity awards) |
Estimated Possible Payouts Under Non-Equity Incentive Plan Awards |
Number of Shares (#) |
All Other Option Awards: Number of Securities Underlying Options (#) |
Exercise or Base Price of Option Awards ($/Sh) |
Grant Date Fair Value of Stock and Option Awards |
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Target ($) |
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Jennifer K. Simpson |
2/8/2017 | | 89 | | | $ | 7,500 | |||||||||||||||||
Barbra C. Keck |
2/8/2017 | | 57 | | | $ | 4,800 | |||||||||||||||||
John Purpura |
2/8/2017 | | 85 | | | $ | 7,200 |
Outstanding Equity Awards at Fiscal Year-End Table2017.
The following table sets forth information relating to unexercised options and unvested restricted shares held by the named executive officers as of December 31, 2017.
Name |
Number of Securities Underlying Unexercised Options (#) Exercisable |
Number of Securities Underlying Unexercised Options (#) Unexercisable |
Option Exercise Price ($) |
Option Expiration Date |
Number of Shares of Stock That Have Not Vested (#) |
Market Value of Shares of Stock That Have Not Vested ($) |
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Jennifer K. Simpson, Ph.D. |
2 | | $ | 26,880 | 11/14/2023 | | | |||||||||||||||
11 | 5 | $ | 6,664 | 6/10/2025 | 12 | 1.08 | ||||||||||||||||
| | | | 89 | 8.01 | |||||||||||||||||
Barbra C. Keck, M.B.A. |
1 | | $ | 26,880 | 11/14/2023 | | | |||||||||||||||
4 | 2 | $ | 6,664 | 6/10/2025 | 4 | 0.36 | ||||||||||||||||
| | | | 57 | 5.13 | |||||||||||||||||
John Purpura, M.S. |
1 | | $ | 381,696 | 11/16/2019 | | | |||||||||||||||
1 | | $ | 26,880 | 11/14/2023 | | | ||||||||||||||||
5 | 3 | $ | 6,664 | 6/10/2025 | 6 | 0.54 | ||||||||||||||||
| | | | 85 | 7.65 |
Options Exercises and Stock Vested Table2017.
The following table sets forth information relating to the vesting during 2017 of restricted stock awards granted to the named executive officers. No stock options were exercised by the named executive officers during 2017.
Name |
Number of shares acquired on vesting (#) |
Value realized on vesting ($) |
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Jennifer K. Simpson |
12 | 262 | ||||||
Barbra C. Keck |
4 | 95 | ||||||
John Purpura |
6 | 131 |
Potential Payments upon Termination or Change of Control.
The following table shows the potential incremental value transfer to each named executive officer under various termination or change-in-control scenarios as of December 29, 2017, the last business day of 2017. Unvested, unexercised stock options and unvested restricted stock awards are valued at the closing market price of the Companys common stock on that date. The actual amounts to be paid out in respect of the other named executive officers can only be determined at the time of such named executive officers actual separation from the Company.
Event | ||||||||||||||||||||
Named Executive Officer(1) |
Retirement or Voluntary Termination Without Good Reason |
Termination for Cause |
Involuntary Termination (Termination Without Cause, or Termination for Good Reason) |
Upon a Change in Control(1) |
Death or Disability Termination |
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Jennifer K. Simpson |
| | | $ | 9 | | ||||||||||||||
Barbra C. Keck |
| | | $ | 5 | | ||||||||||||||
John Purpura |
| | | $ | 8 | |
(1) | Upon a change in control, the vesting of all equity incentive awards is accelerated. The amount shown represents the value of restricted stock units held on December 29, 2017, based on the closing trading price of our common stock on that date. |
Director Compensation2017
The Compensation and Stock Option Committee reviews and recommends to the Board of Directors appropriate director compensation programs for service as directors, committee chairs, and committee members.
In lieu of per-meeting fees, non-employee directors of the Company are paid an annual retainer of $43,000 and certain additional annual retainers for chairing or serving as a member of the committees of the Board as follows:
Name |
Annual Retainer | |||
Board Service |
$ | 43,000 | ||
Chair of Audit Committee |
$ | 20,000 | ||
Member of Audit Committee |
$ | 8,000 | ||
Chair of Compensation and Stock Option Committee |
$ | 12,000 | ||
Member of Compensation and Stock Option Committee |
$ | 5,000 | ||
Chair of Nominating and Corporate Governance Committee |
$ | 8,000 | ||
Member of Nominating and Corporate Governance Committee |
$ | 4,000 |
Dr. Stoll receives an annual retainer fee as Director and Chairman of the Board of $68,000. Additionally, we reimburse all non-employee directors for their reasonable out-of-pocket travel expenses incurred in attending meetings of our Board of Directors or any committees of the Board. Due to the low number of shares remaining available for issuance under the Companys Delcath 2009 Stock Incentive Plan, the Board of Directors did not grant any equity awards to non-employee directors during 2016 which in no way should create any negative inference concerning the Compensation and Stock Option Committees evaluation of their performance.
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The following table sets forth the compensation awarded to, earned by or paid to each non-employee director who served on our Board of Directors in 2017.
Name |
Fees Earned or Paid in Cash |
Stock Awards |
Option Awards |
All Other Compensation |
Total | |||||||||||||||
Harold S. Koplewicz. M.D.(1) |
$ | 45,333 | $ | | $ | | $ | | $ | 45,333 | ||||||||||
Simon Pedder, Ph.D.(2) |
$ | 7,000 | $ | | $ | | $ | | $ | 7,000 | ||||||||||
William D. Rueckert |
$ | 72,000 | $ | | $ | | $ | | $ | 72,000 | ||||||||||
Roger G. Stoll, Ph.D. |
$ | 68,000 | $ | | $ | | $ | | $ | 68,000 | ||||||||||
Marco Taglietti, M.D. |
$ | 65,000 | $ | | $ | | $ | | $ | 65,000 |
(1) | Dr. Koplewicz resigned as a director in September 2017. |
(2) | Dr. Pedder was appointed as a director in November 2017. |
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The following tables contain information regarding the beneficial ownership of our common stock as of April 20, 2018, held by: (i) each of our directors; (ii) each of our named executive officers in the Summary Compensation Table; (iii) all of our directors and executive officers as a group; and (iv) each person or group known by us to own beneficially more than 5% of the outstanding common stock. We are not aware of any 5% or more holders of our Common Stock as of April 20, 2018 except as set forth below. The information set forth in the table below excludes shares issuable upon exercise of our outstanding warrants held by certain investors that are presently exercisable, subject to limitations on exercisability for more than 4.9% or 9.9% of our outstanding shares of common stock, depending upon the particular investor. Except as indicated in the footnotes below, the address of the persons or groups named below is c/o Delcath Systems, Inc., 1633 Broadway, Suite 22C, New York, New York 10019.
Directors and Officers
Shares Beneficially Owned(1) |
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Name of Beneficial Owner: |
Number | Percent | ||||||
Named Executive Officers and Directors: |
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Jennifer K. Simpson, Ph.D.(2) |
137 | * | ||||||
John Purpura, M.S.(3) |
109 | * | ||||||
Barbra C. Keck, M.B.A.(4) |
75 | * | ||||||
Simon Pedder, PhD.(5) |
| * | ||||||
Roger G. Stoll, Ph.D.(6) |
9 | * | ||||||
William D. Rueckert(7) |
17 | * | ||||||
Marco Taglietti, M.D.(8) |
49 | * | ||||||
All directors and executive officers as a group (7 people)(9): |
396 | * |
* | Less than 1% |
(1) | Except as indicated in these footnotes: (i) the persons named in this table have sole voting and investment power with respect to all shares of common stock beneficially owned; (ii) the number of shares beneficially owned by each person as of April 20, 2018, includes any vested and unvested shares of restricted stock and any shares of common stock that such person or group has the right to acquire within 60 days of April 20, 2018, upon the exercise of stock options; and (iii) for each person or group included in the table, percentage ownership is calculated by dividing the number of shares beneficially owned by such person or group by the sum of the 448,496,819 shares of common stock outstanding on April 20, 2018, plus the number of shares of common stock that such person or group has the right to acquire within 60 days of April 20, 2018. |
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(2) | Includes 16 shares of common stock, which Dr. Simpson has the right to acquire upon exercise of outstanding options exercisable within 60 days of April 20, 2018. |
(3) | Includes 10 shares of common stock, which Mr. Purpura has the right to acquire upon exercise of outstanding options exercisable within 60 days of April 20, 2018. |
(4) | Includes 7 shares of common stock, which Ms. Keck has the right to acquire upon exercise of outstanding options exercisable within 60 days of April 20, 2018, and 4 shares held in a joint account with her spouse. |
(5) | Dr. Pedder has not yet received an equity grant. |
(6) | Includes 5 shares of common stock, which Dr. Stoll has the right to acquire upon exercise of outstanding options exercisable within 60 days of April 20, 2018 |
(7) | Includes 10 shares of common stock, which Mr. Rueckert has the right to acquire upon exercise of outstanding options exercisable within 60 days of April 20, 2018. |
(8) | Includes 10 shares of common stock, which Dr. Taglietti has the right to acquire upon exercise of outstanding options exercisable within 60 days of April 20, 2018. |
(9) | Includes 60 shares of common stock, which certain directors and executive officers have the right to acquire upon exercise of outstanding options exercisable within 60 days of April 20, 2018. |
Item 13. | Certain Relationships and Related Transactions, and Director Independence. |
The information required for this Item is incorporated by reference from our Proxy Statement.
Transactions with Related Persons. We have adopted a written policy for the review and approval or ratification of transactions between Delcath and Related Parties (as defined below). Under the policy, our Nominating Committee will review the material facts of proposed transactions involving Delcath in which a Related Party will have a direct or indirect material interest. The Nominating Committee will either approve or disapprove Delcaths entry into the transaction or, if advance approval is not feasible, will consider whether to ratify the transaction. The Nominating Committee may establish guidelines for ongoing transactions with a Related Party, and will review such transactions at least annually. If the aggregate amount of the transaction is expected to be less than $200,000, such approval or ratification may be made by the Chair of the Committee. In determining whether to approve or ratify a transaction with a Related Party, the Nominating Committee (or Chair) will consider, among other factors, whether the transaction is on terms no less favorable than terms generally available to an unaffiliated third-party and the extent of the Related Partys interest in the transaction.
Certain transactions are deemed pre-approved under the policy, including compensation of executive officers and directors (except that employment of an immediate family member of an executive officer requires specific approval), and transactions with a company at which the Related Partys only relationship is as a non-officer employee, director, or less than 10% owner if the aggregate amount involved does not exceed 2% of such companys total annual revenues (or, in the case of charitable contributions by Delcath, 2% of the charitys total annual receipts). Pre-approval is not required if the amount involved in the transaction is not expected to exceed $120,000 in any calendar year.
For purposes of the policy, a Related Party is generally anyone who since the beginning of the last full fiscal year is or was an executive officer, director or director nominee, owner of more than 5% of the common stock, or immediate family member of any of such persons.
No related person transactions occurred during 2017.
Compensation Committee Interlocks and Insider Participation. During 2017, Marco Taglietti and William D. Rueckert served as members of our Compensation and Stock Option Committee. None of the current members or members serving during 2017 of the Compensation and Stock Option Committee is a current or former officer or employee of Delcath at the time of their service on the Compensation and Stock Option Committee, nor did any Compensation and Stock Option Committee member engage in any related person transaction that would be required to be disclosed under Item 404 of Regulation S-K. During 2017, none of Delcaths executive officers served on the compensation committee (or equivalent) or on the board of directors of another entity whose executive officers served on the Compensation and Stock Option Committee or our Board of Directors.
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Board Independence. The Board has determined that four of our five directors (each of Simon Pedder, William D. Rueckert, Roger Stoll and Marco Taglietti) are independent directors within the meaning of the NASDAQ listing rules.
Certain Anti-Takeover Provisions of Delaware Law and our Certificate of Incorporation and Bylaws
We are not subject to Section 203 of the Delaware General Corporation Law, which prohibits Delaware corporations from engaging in a wide range of specified transactions with any interested stockholder, defined to include, among others, any person other than such corporation and any of its majority owned subsidiaries who own 15% or more of any class or series of stock entitled to vote generally in the election of directors, unless, among other exceptions, the transaction is approved by (i) our board of directors prior to the date the interested stockholder obtained such status or (ii) the holders of two thirds of the outstanding shares of each class or series of stock entitled to vote generally in the election of directors, not including those shares owned by the interested stockholder.
Staggered Board of Directors
Our certificate of incorporation and by-laws provide that our board of directors be classified into three classes of directors of approximately equal size. As a result, in most circumstances, a person can gain control of our board only by successfully engaging in a proxy contest at two or more annual meetings.
Authorized But Unissued Shares
Our authorized but unissued shares of common stock and preferred stock are available for future issuances without stockholder approval and could be utilized for a variety of corporate purposes, including future offerings to raise additional capital, corporate acquisitions, employee benefit plans and stockholder rights plans. The existence of authorized but unissued and unreserved common stock and preferred stock could render more difficult or discourage an attempt to obtain control of us by means of a proxy contest, tender offer, merger or otherwise.
Item 14. | Principal Accountant Fees and Services. |
The aggregate fees billed by Grant Thornton for services rendered as our independent registered public accounting firm during the fiscal years ended December 31, 2017 and 2016, respectively:
Fiscal Year | ||||||||
2017 | 2016 | |||||||
Audit Fees |
$ | 576,450 | 326,500 | |||||
Audit-Related Fees |
| | ||||||
Tax Fees |
| | ||||||
|
|
|
|
|||||
Total |
$ | 576,450 | 326,500 | |||||
|
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Audit Fees. These are fees for services rendered in connection with the audit of the annual financial statements included in our annual reports on Forms 10-K; the review of the financial statements included in our Quarterly Reports on Forms 10-Q; the audit of our internal control over financial reporting; and for services that are normally provided by an independent auditor in connection with statutory and regulatory filings or engagements.
Pre-approval Policies: Audit and Non-Audit Services. The Audit Committee pre-approves all audit services and the terms of such services and permissible non-audit services provided by Delcaths independent registered public accounting firm, prior to its engagement for the provision of such services. The Chair of the Audit Committee
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has been delegated the authority by the committee to pre-approve interim services by Delcaths independent registered public accounting firm; provided the Chair reports all such pre-approvals to the entire Audit Committee at the next Committee meeting. There were no non-audit services provided to Delcath by our independent registered public accounting firm for 2016 and 2017 that required review by the Audit Committee.
Item 15. | Exhibits and Consolidated Financial Statement Schedules |
The following documents were filed as part of the original Annual Report on Form 10-K, filed on March 16, 2018:
1. Consolidated Financial Statements: The following Consolidated Financial Statements and Supplementary Data of Delcath and the Report of Independent Registered Public Accounting Firm included in Part II, Item 8:
| Consolidated Balance Sheets at December 31, 2017 and 2016 |
| Consolidated Statements of Comprehensive Loss for the years ended December 31, 2017, 2016 and 2015 |
| Consolidated Statements of Stockholders Equity for the years ended December 31, 2017, 2016 and 2015 |
| Consolidated Statements of Cash Flows for the years ended December 31, 2017, 2016 and 2015 |
| Notes to Consolidated Financial Statements |
2. Exhibits: The exhibits listed in the accompanying Exhibit Index were filed or incorporated by reference as part of the Annual Report on Form 10-K, filed on March 16, 2018, except as noted below as being filed herewith.
Exhibit Index
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| Portions of this exhibit have been redacted and are subject to a confidential treatment request filed with the Secretary of the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. |
* | Indicates management contract or compensatory plan or arrangement. |
** | Filed herewith. |
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Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
DELCATH SYSTEMS, INC. |
/s/ Jennifer K. Simpson |
Jennifer K. Simpson |
President and Chief Executive Officer |
(Principal Executive Officer) |
Dated: April 30, 2018 |
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature |
Title |
Date | ||
/s/ Jennifer K. Simpson |
President and Chief Executive Officer | April 30, 2018 | ||
Jennifer K. Simpson | (Principal Executive Officer) | |||
/s/ Barbra C. Keck |
Chief Financial Officer | April 30, 2018 | ||
Barbra C. Keck | (Principal Financial Officer and Principal Accounting Officer) | |||
/s/ Roger G. Stoll, Ph.D. |
Chairman of the Board | April 30, 2018 | ||
Roger G. Stoll, Ph.D. | ||||
/s/ Simon Pedder, Ph.D. |
Director | April 30, 2018 | ||
Simon Pedder, Ph.D. | ||||
/s/ William Rueckert |
Director | April 30, 2018 | ||
William Rueckert | ||||
/s/ Marco Taglietti |
Director | April 30, 2018 | ||
Marco Taglietti |
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